ISRCTN17674908进行中（未招募）未知
The effect of acute aerobic exercise on the time spent in hypoglycaemia after Roux-en-Y gastric bypass
niversity of Leicester0 个研究点目标入组 18 人开始时间: 2021年10月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged >=18 years but less than 75 years
- •2. Subjects >=1 year after gastric bypass (RYGB)
- •3. Able to understand written and spoken English
- •4. Able to provide informed consent
排除标准
- •Current exclusion criteria as of 19/01/2023:
- •1. A current diagnosis of type 2 diabetes (defined as HbA1C =6.5% at screening blood tests or HbA1C <6.5% at screening bloods but on glucose-lowering medications over last 3 months)
- •2. An eGFR value of <=30 ml/min over the last 6 months
- •3. History of revisional bariatric surgery, except of previous gastric banding which has been removed
- •4. Any other bariatric operation which is not RYGB (single anastomosis bypass patients will be excluded)
- •5. On any medications that affect glucose levels (e.g. glucose-lowering medications or steroids)
- •6. Any contraindications/limitations to AEX self-reported or identified in the maximal exercise test (e.g orthopaedic limitations, severe cardiovascular/pulmonary disease, chair bound)
- •7. An established diagnosis of PHH
- •8. Systolic blood pressure > = 160mmHg or Diastolic blood pressure > = 100mmHg at screening
- •9. Individuals which are taking part in regular structured exercise
- •10. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
- •11. History of epilepsy
- •12. HbA1C >=6.5% or >=48 mmol/l at screening blood tests
- •13. Haemoglobin (Hb) <100 g/L at screening blood tests
- •14. Currently pregnant or breastfeeding
- •15. Recent active infection (over the last 10 days)
- •16. Adrenal insufficiency and/or substitution with glucocorticoids
- •17. >180 kg at screening due to the maximum weight capacity of the treadmill
- •18. Participating in another research study involving intervention within 3 months of screening
- •Previous exclusion criteria:
- •1. A history of diabetes mellitus (type 1 or type 2 diabetes mellitus)
- •2. An eGFR value of <=30 ml/min over the last 6 months
- •3. History of revisional bariatric surgery, except of previous gastric banding which has been removed
- •4. Any other bariatric operation which is not RYGB (single anastomosis bypass patients will be excluded)
- •5. On any medications that affect glucose levels (e.g. glucose-lowering medications or steroids)
- •6. Any contraindications/limitations to AEX self-reported or identified in the maximal exercise test (e.g orthopaedic limitations, severe cardiovascular/pulmonary disease, chair bound)
- •7. An established diagnosis of PHH
- •8. Systolic blood pressure > = 160mmHg or Diastolic blood pressure > = 100mmHg at screening
- •9. Individuals which are taking part in regular structured exercise
- •10. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
- •11. History of epilepsy
- •12. HbA1C >=6.5% or >=48 mmol/l at screening blood tests
- •13. Haemoglobin (Hb) <100 g/L at screening blood tests
- •14. Currently pregnant or breastfeeding
- •15. Recent active infection (over the last 10 days)
- •16. Adrenal insufficiency and/or substitution with glucocorticoids
- •17. >180 kg at screening due to the maximum weight capacity of the treadmill
- •18. Participating in another research study involving intervention within 3 months of screening
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